KR101205808B1 - Cassette assembly - Google Patents

Abstract

A sterilizer cassette having one or more cells containing a sterilant is received in the sleeve and the sleeve holds a barcode encoding lumen claims. Lumen claims relate to the sterilization cycle in which the cassette is designed.

Sterilizers, Cassettes, Lumen Claims, Sleeves

Description

Cassette assembly {CASSETTE ASSEMBLY}

1 is a block diagram of a sterilization apparatus using a cassette according to the present invention.

2 is a rear view of the cassette processing system according to the present invention.

3 is a front view of the cassette processing system of FIG.

4 is a front view of the cassette processing system of FIG. 2 showing the cassette collection box spent;

FIG. 5 is a rear view of the cassette processing system of FIG. 2 showing a carriage in the insertion position. FIG.

6 is a rear view of the cassette processing system of FIG. 2 showing the carriage as it moves toward the home position. FIG.

7 is a rear view of the cassette processing system of FIG. 2 showing the carriage in position for reading a barcode on the cassette.

8 is a rear view of the cassette processing system of FIG. 2 showing the carriage in a home position.

9 is a front view of the cassette processing system of FIG. 2 showing the carriage in a position for tapping a first cell of the cassette.

Fig. 10 is a sectional view of the cassette showing the cells therein.

FIG. 11 is a front view of the cassette processing system of FIG. 2 showing the upper needle and the lower needle on the extractor subsystem passing through the first cell of the cassette.

12 is a front view of the cassette processing system of FIG. 2 showing the upper needle and the lower needle on the extractor subsystem in a position to penetrate the last cell of the cassette;

FIG. 13 is a front view of the cassette processing system of FIG. 2 showing the ejected cassette. FIG.

14 is a flowchart of a cassette processing procedure.

15 is a rear view of an alternative embodiment of the cassette processing system of the present invention using RFID technology.

FIG. 16 shows a memory map of the RFID tag of the cassette shown in FIG. 15; FIG.

FIG. 17 is a top plan view showing an unfolded blank for forming the spent cassette collection box of FIG. 4. FIG.

18 shows the blank of FIG. 17 in a folded state to form a spent cassette collection box.

19 is a perspective view of a cassette according to the present invention with an outer sleeve;

20 is a side view illustrating a cassette processing system for processing the sleeve and cassette of FIG. 19;

Figure 21 is a plan view showing a cassette according to the present invention accommodated in a packaging system according to the present invention.

22 is a plan view of the packaging system and cassette of FIG. 21 before finally closing the package.

This invention is a continuation of US patent application Ser. No. 10 / 856,435, filed May 28, 2004, the contents of which are incorporated herein by reference.

The present invention relates to cassettes for delivering a sterilant to an instrument sterilizer, and more particularly to cassettes encoded with machine readable lumen claims and their packaging.

One popular method for disinfecting devices such as medical devices is to contact a gaseous chemical fungicide such as hydrogen peroxide with the devices. In many such sterilizers, it is desirable to deliver the sterilizer in a liquid state and to vaporize it in the sterilizer. A particularly convenient and accurate way to deliver a liquid sterilizer is to place a predetermined amount of sterilizer in a cassette and deliver the cassette to the sterilizer. The sterilizer then automatically extracts the sterilant from the cassette and uses it for sterilization. Typically, the cassette consists of multiple cells containing the same amount of liquid sterilizer, so that the disinfection procedure will use sterilizers from more than one cell. Such a system is currently available with STERRAD®, a sterilization system available from Advanced Sterilization Product of Irvine, California, USA.

US Pat. Nos. 4,817,800, 4,869,286, 4,899,519, 4,909,287, 4,913,196, 4,938,262, 4,941,518, 5,882,611, 5,887,716 and 6,412,340, each of which are incorporated herein by reference Disclosed are cassettes and a method for discharging a liquid bactericide from a cell within the cassette.

It is known to use barcodes on the cassette or on the sleeve in which it is received. Typically, certain models of sterilizers use specific cassette designs. The barcode on the cassette may include information recording the model number of the sterilizer to be designed and the cassette expiration date. Thus, the sterilizer determines by reading the code whether a failed cassette or a cassette whose expiration date has passed is inserted and rejects the cassette at that time.

A cassette for a sterilizer according to the present invention comprises a body having one or more cells containing a large amount of liquid sterilant. The body is housed in a sleeve and a lumen claim is encoded in a barcode on the sleeve.

Preferably, the barcode encodes an identifier for the type and model of sterilizer with which the lumen claim is associated.

In one embodiment of the present invention, the fungicide contains a hydrogen peroxide solution.

In one embodiment of the present invention, the lumen claim defines the length and inner diameter of the lumen. In addition, the lumen claims may define the materials that make up the lumen. Identifiers representing length and inner diameter may be encoded or the actual length and inner diameter may be encoded.

The barcode of one embodiment of the present invention remains on a label attached to the sleeve. Alternatively, the barcode is printed on the sleeve.

In a preferred embodiment, the cassette has a plurality of cells.

Overall composition of sterilizer

1 shows a block diagram of forming a gaseous sterilizer 10 using a cassette processing system 12 according to the present invention. The sterilizer 10 includes a vacuum chamber 14 and a vacuum pump 16 for evacuating the atmosphere from the chamber. The vaporizer 18 receives the liquid sterilizer from the cassette processing system 12 and supplies it to the vacuum chamber 14 in a gaseous state. A screen grid electrode 20 is provided inside the vacuum chamber 14 to excite the contents in a plasma state during part of the disinfection cycle. Micro filtered vents 22 and valves 24 allow sterile air to enter and release the vacuum chamber 14. The control system 28 is connected to all the major components in the sterilizer 10, sensors and the like to control the sterilization cycle.

Typical sterilization cycles may include vacuuming the vacuum chamber 14 and powering the electrode 20 to evaporate and extract water from the vacuum chamber 14. Thereafter, power to the electrode 20 is cut off, and a low vacuum of 1 torr or less is formed in the vacuum chamber 14. A sterilant, such as a hydrogen peroxide solution, is vaporized by the vaporizer 18 and introduced into the vacuum chamber 14 where the sterilant is diffused to contact the articles to be disinfected and to remove microorganisms present in these articles. Near the end of the cycle, power is again applied to the electrodes 20 and the fungicide is excited to be in a plasma state. Power supply to the electrodes 20 is reduced and filtered air is sucked through the valve 24. This process can be repeated. US Patent Application Publication 2003/0235511 to Jacobs et al., Incorporated herein by reference, describes this cycle in detail.

Cassette processing system

2-4, the cassette processing system 12 according to the present invention is shown. The system as a whole comprises a carriage 32, a lead screw 36 and a motor 38, an extractor subsystem 40 and a scanner 42 for the support of the cassette 34. .

The pallet 32 has a bottom panel 44, a side panel 46, a top panel 48 and a top panel 48 and a bottom panel 44 to capture the cassette 34. Small vertical flanges (50, 52). The bottom panel 44, side panel 46 and top panel 48 take the form of outward extension at the inlet 54 of the carriage to assist with the insertion of the cassette. Two spring catches 56 on the flanges 50, 52 engage the irregular surfaces of the cassette 34 to firmly place the cassette 34 inside the carriage 32.

The carriage 32 moves along the lead screw 36 and is supported on an upper rail 58. A lead screw nut 60 attached to the bottom panel 44 and having a threaded opening 62 and a non-threaded opening 63 receives the lead screw 36 and rotates the lead screw 36. In response, the carriage 32 forms a horizontal movement. Flanges 64 extend outwardly from the top panel 48, and other flanges 66 extend outwardly from the side panel 66, each of which receives an upper rail 58. Openings 69. The motor 38 is preferably a stepping motor and is connected to the lead screw 36 to precisely control the horizontal position of the cassette 34 relative to the frame 68.

The extraction assembly 40 includes an upper needle 70 and a lower needle 72 each taking a columned configuration. The upper needle is connected to an air pump 74 which pushes air through the upper needle 70. The lower needle 72 is connected to a valve 76 from which plumbing is plumbed to the vaporizer 18.

The scanner 42 is oriented to read the barcode 80 on the cassette 34 and the barcode 82 on the spent cassette collection box 84. When the cassette 34 is inserted into the carriage 32, the scanner 42 reads the cassette barcode 80. This barcode 80 is well encoded with information about the contents of the cassette 34, including lot numbers and expiration dates. This information can be used to determine if this cassette 34 is of the correct type and whether the cassette has been used in the present system before and thus is partially empty. This code will communicate with the control system 28 to make such decisions.

The scanner 42 can also recognize the cassette collection box barcode 82 consumed when the carriage 32 moves away from the scanner 42 and moves inward. Each spent cassette collection box 84 preferably has two barcodes 82, one of which is located at each opposite corner, so that no matter which end of the spent cassette collection box was inserted first The scanner 42 is able to recognize one of the bar codes. With the consumed cassette collection box 84 filled, the control system states that the consumed cassettes 34 block the barcode 82 and that the barcode is no longer capable of receiving the consumed cassettes 34. Informed in (28). Preferably this message will be output to the user on a display screen (not shown) or the like. If the cassette 34 is empty, the cassette is not ejected and a new cycle until the consumed cassette collection box 84 with the capacity to accommodate the consumed cassette 34 is moved into the sterilizer 10. Will not proceed.

A forward flag 86 and a rear flag 88 project outwardly and downwardly from the pallet side panel 46. These flags slide through slot 90 in slot sensor 92 which senses their presence inside slot 9, such as by blocking light. Movement of the front flag 86 and the rear flag 88 through the slot sensor 92 provides the control system 28 with a reference position of the pallet 32.

The upper panel 48 of the pallet 32 may rotate about the upper rail 58. The spring 94 between the top panel 48 and the side panel 46 deflects the top panel 48 downward to secure the cassette 34 inside the carriage 32. A disposing cam 96 is seated behind the side panel 46 and aligned with the ejecting tab 98, which extends downwardly from the top panel 48 outwards, And as the top panel 48 rotates upward, it can protrude through the opening 100 on the side panel 46. This rotation of the top panel 48 releases its fixation on the cassette 34, and the ejection tab 98 protrudes through the opening 100, thereby carrying the cassette 34 with the carriage 32. Push outwards to enter the spent cassette collection box.

The processing cam 96 controls the rotation of the top panel 48. The cam comprises a generally triangular shape, with an outward side 102, an anterior side 104 and a rear side 106. Returning now to FIG. 5, this cam is rotatably mounted to the upwardly extending spindle 108. The spring 110 deflects the treatment cam 96 counterclockwise to press the outward surface 102 into contact with the abutment 112. With the inward movement of the carriage 32, the release tab 98 is cambed along the rear face 106 of the treatment cam 96, so that the treatment cam 96 rotates clockwise and In this case, the discharge tab 98 can pass through without rotating the top panel 48. However, with outward movement of the pallet 32, the release tab is cambed along the omnidirectional surface 104 of the treatment cam. During this operation, the outward surface 102 of the processing cam 96 and the supporting portion 112 come into contact with each other to prevent rotation of the processing cam 96. Camming of the release tab 98 thus causes the tab to move laterally toward the side panel 46 such that the top panel 48 is rotated upwards and the cassette 32 is moved to the carriage 32. ) Is released.

Prior to insertion of the cassette 34, the carriage 32 is fully retracted to its outward position (to the left as shown in FIG. 5). Also in this position the front end 114 on the lead screw nut 60 comes into contact with the stop 116 and thus the position of the carriage 32 is actively set. 6 again, manual insertion of the cassette 34 causes the carriage 32 to move inwards (to the right as shown in FIG. 6) and into the slot sensor 92 into the front flag ( Move 86). This movement is preferably made of a physical force for inserting the cassette 34, but as soon as the torque sensor or the like senses the force that the cassette 34 is inserted into the carriage 32, the stepping motor 38 is responsible for this movement. Can be applied. Allowing this movement to be derived from the insertion force of the cassette 34 ensures that the cassette 34 is sufficiently settled in the carriage 32 before this movement begins.

Once the front flag 86 is read by the slot sensor 92, the stepping motor 38 is responsible for the movement and moves the carriage 32 inward. 7 again, during this step the scanner 42 scans the barcode 80 on the cassette 34. The control system 28 interprets the information from this barcode 80 and determines whether this cassette 34 has been used in the sterilizer 10 before, whether the cassette contains fresh fungicides and other appropriate information. Judge. Preferably, the information on the barcode 80 is encrypted to prevent the unauthorized party from creating cassettes that may not meet the quality standards required for proper disinfection.

If the control system 28 rejects the cassette 34, the carriage 32 is moved inward enough to allow the ejection tab 98 to pass through the processing cam 96, after which the rejected cassette 34 Return to the insertion position shown in Figure 5 to release the. Once the cassette 34 is approved, the carriage 32 continues to move inward to the home position, shown in FIG. 8, where the rear flag 88 only passes from the slot sensor 92.

Turning now to FIGS. 9 and 10, the cassette 34 includes a plurality of cells 118 containing a liquid sterilant 120. Various structures of cassettes can be used. The cassette 34 shown is preferably formed of an injection molded polymer, such as high impact polystyrene, high density polyethylene, or high density polypropylene, to form a reinforcing outer shell 122 surrounding the individual cells 118. And the cells 118 are formed of blow molded polymer, such as low density polyethylene. However, a more rigid material can be used to form the cassette cells 118, in which case the outer wall 122 can be omitted. In the cassette 34 shown, the upper opening 124 and the lower opening 126 penetrating the outer wall 122 allow the upper needle 70 and the lower needle 72 to penetrate the outer wall. The cell 118 is formed of a material that can be easily penetrated by the needle. If the cell 118 is formed of a more rigid material, a thin thickness of material may be provided at the positions penetrated by the needles 70 and 72.

The control system 28 uses the home position of FIG. 8 as a reference position for placing several cells 118 in front of the extractor subsystem 40. By moving the carriage 32 from its home position by a predetermined amount, a given cell 118 can be moved to face the extractor system 40. In FIG. 9, one of the cells is located in front of the extractor system 40. Returning now to FIG. 11 again, the actuator 128 drives the extractor subsystem 40 toward the cassette such that the upper needle 70 and the lower needle 72 penetrate the upper opening 124 and the lower opening 126. And enter cell 118. After the needles are sufficiently extended, the air pump 74 introduces air into the cell 118 through the upper needle 70. The system waits for a few seconds before driving the air pump 74 and opening the valve 76 to ensure proper placement and to secure needles inside the cell 118. The sterilant 120 flows out through the lower needle 72 and is sent through the pipe to the vaporizer 120. After sufficient time to extract the sterilant 120, the air pump 74 is powered off and the actuator recovers the extractor subsystem 40 from the cassette 34.

The vaporizer 18 is connected to a vacuum chamber 14 that allows the lower needle 72 to be easily positioned below atmospheric pressure. Thus, the pump 74 may optionally be replaced by a valve (not shown) open to the atmosphere, in which case the incoming atmospheric air will provide the driving force to empty the cell 118.

Rather than using the upper needle 70 and the lower needle 72, one needle will pass through two lumens. One of the lumens will provide a compressed gas and the other will extract the liquid fungicide. A further alternative arrangement is to penetrate the cell 118 vertically or substantially vertically from the upper portion of the cell 118, preferably with such double lumen needles as above. This will minimize leakage around the holes created by the needle entering the cell 118. Also with this entry, the tip of the needle comes close to the lowest point of the cell for maximum extraction efficiency. If one wants to extract less than the entire contents of the cell 118, one method is to place the fungicide extraction needle, such as the lower needle 72 or the double lumen needle described above, at the level of the cell 118 where it is desired to extract. . Liquid sterilizer higher than this position will be extracted and less sterilizer will remain. This is particularly convenient using the vertical movement needle described above.

12, whenever the control system 28 determines that a new dose of sterilant 120 is needed, the stepper motor 38 places the next cell 118 in front of the extractor subsystem 40. The cassette is moved, and a new extraction is started. Multiple extractions can be used for a given disinfection cycle. In the event that the cassette 34 is depleted, the carriage 32 is moved to the insertion position, so that the release tab 98 is rotated upward to rotate the top panel 48 as described above and shown in FIG. 13. Camming along the processing cam 96, the ejection tab 98 protrudes through the opening 100 to drive the cassette 34 out of the pallet 32. The cassette 34 falls into the spent cassette collection box 84 and the carriage 32 returns to the insertion position as shown in FIG.

The foregoing description has described in some detail the operation of the cassette processing system. 14 shows the basic operation of the cassette processing system 12 in the form of a block diagram.

Lumen claim

Typically, sterilizers and their cycle variables have been optimized to enable disinfection of the most challenging challenge loads possible here so as not to unduly limit the devices to be disinfected. Thin and narrow lumens, one of the most challenging areas to sterilize, have become the de facto standard in defining the effectiveness of the disinfection process, ie the ability to disinfect devices with lumens of constant diameter and length. The longer and narrower the lumen that can be disinfected, the more effective the sterilizer cycle is. Thus, the sterilizer is said to achieve a lumen claim consisting of lumen diameter x lumen length, for example 1 mm x 100 mm. The lumen claim also includes a material forming this lumen. Typically, this lumen claim will be a claim approved by a regulatory agency, such as the US Food and Drug Administration, but may only represent the sterilizer and the lumen that the cycle effectively sterilizes. Typically, sterilization involves 6 log reduction for challenging microorganisms. A good challenging microorganism for hydrogen peroxide based sterilization systems is Geobacillus-stearothermophilus.

Rather than always running the sterilizer to achieve maximum lumen claims, it is desirable to run the sterilizer 10 in different cycles depending on the devices loaded for disinfection. Preferably, the operator selects lumen claims based on the most challenging lumen device loaded when loading sterilizer 10 and then inputs the lumen claims to control system 28. Alternatively, the devices can be coded themselves, such as a barcode scanned when the device is loaded, and the control system 28 is suitable to satisfy a particular lumen claim based on the most challenging lumen device scanned. Select a cycle. A series of lumen claim cycles programmed in the sterilizer may include: a) 1 mm × 1,000 mm, b) 1 mm × 500 mm, c) 2 mm × 100 mm and d) no lumens. Cycles can be adjusted for less burdened lumen claims, ie spraying less fungicide, using a lower concentration of fungicide, using a shorter contact time or using a less burdened vacuum (high pressure), etc. to be. As with this less demanding case, less lumen claims are required. In general, the use of lower concentrations of fungicides can provide advantages such as less toxic treatments for the tools to be sterilized.

In order to provide flexibility in optimizing different lumen sterilization cycles, cassettes 34 are provided with a good amount of biocide optimized for a given lumen claim cycle. Preferably, lumen claims are encoded in barcode 80 along with other data, such as the sterilizer model and expiration date intended for cassette 34.

The proposed data layout for the barcode 80 includes the following areas: a) Sterilizer model intended for the cassette 34 (three binary numbers associated with the reference table), b) Expiry date (fixed) 8 binary digits representing months from date), c) lumen claims (three binary digits). Alternatively, the lumen claims can be represented by the inner diameter and length regions of the separate lumens, preferably in millimeters and decimeters, respectively. In addition, as shown in the last column of Table 1a, some lumens with different dimensions may nevertheless have equivalent processing conditions. Preferably, one of the equivalent lumens may be coded on the barcode 80 with the sterilizer control system programmed for this equivalent. Other coding schemes are possible within the scope of the present invention.

Tables 1a and 1b show how certain variables of the cycle can be modified to handle specific lumens.

TABLE 1a

TABLE 1b

Beyond just entering lumen data, control system 28 can be configured to accept multiple inputs and use this information to determine how the next disinfection cycle should be performed. These inputs include the following: whether the load is packaged (such as "CSR" wraps from Central Supply Romm), the weight of the load, the number of items (and more preferably the number of items, such as rigid or flexible endoscopes). And the type, material of the load, such as the proportion of plastics, the presence or ratio of superabsorbent polymers of hydrogen peroxide, such as polyamide, polyurethane, silicone rubber, PVCs, acrylic resins, polysulfones and the like and complete disinfection or only a high level of disinfection. Whether it is necessary). Some of these inputs can be determined by a machine equipped with a suitable sensor, for example the weight of a load that can be determined by measuring plasma power or through a particular type of balance well incorporated into the sterilizer 10.

The sterilizer 10 may be provided with a plurality of sensors including sensors for measuring temperature and pressure, sterilant concentration, plasma power. These are used by the control system to adjust the parameters of the disinfection cycle in order to properly handle the load in the most efficient manner in conjunction with user input. Table 2 shows how the cycle can be modified for various user inputs.

[Table 2]

Cycle response to user input

Load property answer Control mechanism Disinfection or high level sterilization High levels of sterilization—low sterilant concentration or / and mass / shortened exposure time
Disinfection-High Sterilizer Concentration or / and Mass The disinfection / sterilization concentration levels and amounts are determined to reach the required disinfection level. The concentration / amount is monitored by a disinfectant sensor to maintain the required level. Packed or unpackaged loads Unpacked-low concentration / mass distribution
Packing-higher concentration / mass distribution The disinfection / sterilization concentration levels and amounts are determined to reach the required disinfection level. The concentration / amount is monitored by a disinfectant sensor to maintain the required level. Load volume and weight Large volume: Absorb as much as possible
Large weight: higher concentration possible Monitor and maintain the required level of disinfection / sterilization. Set the temperature at a higher level to reduce the absorption and concentration effects. Preload the load if necessary.A large amount of aeration / remaining treatment. Loads include materials that are disintegrators or absorbers for disinfection / sterilization. Higher injection mass / concentrations and temperatures may be required. Monitor and maintain the required level of disinfection / sterilization. If there is excessive absorption (check from the sterilization concentration sensor output) Loads include lumens: short vs long Higher concentrations and / or masses, longer exposure times and pretreatment pressure gradients. Set concentration and pressure gradient levels accordingly.

In one aspect of the invention, the user will initially enter loads and process data to select between one or more standard cycles in operation or between one or more user program cycles, or to design a cycle. In the choice of entering load data, the user may choose whether to sterilize initially or to a high level of sterilization. If sterilization is selected, the user will enter if the load is contained in packaged containers or items. Secondly, the user will enter whether the load contains lumens. For loads without lumens, the total weight and material of the load will be entered. These inputs can be made on a per item basis or collectively. For lumens, additional data such as lumen length and inner diameter will be entered. Again, this data can be entered as the single most challenging lumen or item by item. Third, the user will enter load preliminary information such as whether preheating or water removal steps should be performed with the load. Alternatively, the control system recommends or determines whether these steps should be performed based on the data entered. These steps can extend the overall process time, and in certain situations the user may choose to exclude the use to speed up the cycle. Fourthly, the user will enter data on the source of the sterilizer (continuous volume or cassette type), the concentration of the sterilizer, the volume of the sterilizer and the type of the sterilizer. Again, some of these may rather be recommended or determined by the control system based on the input data, which may also provide a user with a message regarding the type of cassette to be mounted, for example. Finally, information on residue removal may be entered, i.e. whether the residue removal step should be killed at the end of the cycle and whether heat, plasma, sterile air purification, vacuum or combinations thereof should be used, etc. . Again, this information may be recommended or determined by the control system rather based on the data entered. The user has the option to save this cycle set-up, so that it can be selected from the cycle menu for future cycles for similar devices. Names may be provided to the cycle setup by a set of surgical instruments or the like for easy retrieval of suitable cycles in the future.

Determinations of cycle changes can be made based on table look-ups that use cycle corrections based on known cycle changes related to the load change and preferably sponsored by the test data. have. For example, tests run on lumens of varying diameter and ID can determine exposure times and sterilization concentrations resulting in reliable sterilization. In addition, calculated values of integrated bactericidal exposure (amount and time) can be used. For example, experiments have shown that a special lumen can be successfully sterilized by a special integrated sterilant exposure, i.e. changing the amount or time while still maintaining the overall integrated exposure results in reliable sterilization. Will be achieved.

The system for reading barcodes in cassette 34 and consumed cassette box 84 may be replaced with a radio frequency identification tag, commonly known as an RFID tag. The RFID system 130 is shown in FIG. 15. The system is connected via a SPDT reed relay 134 to a cassette insertion antenna 136 disposed on the carriage 32 and a cassette disposal antenna 138 disposed under the spent cassette box 84. 132. Each cassette 34 has a cassette RFID tag 140 attached thereto. Similarly, each spent cassette collection box 84 is attached with a collection box RFID tag 142. Preferably, the controller 132 includes a Texas Instruments multifunction reader module S4100, and the RFID tags 140, 42 comprise a Texas Instruments RFID tag RI-101-112A, each at Texas Instruments, Dallas, Texas, USA. You can buy it.

The control system 28 (FIG. 1) selects one antenna, for example the casing insertion antenna 136, and transmits a signal to the relay 134 to connect the antenna and the RFID controller 132. . The antenna reads information stored in the cassette 34 and the cassette inserted RFID tag 140 identifying its contents. The information reading is similar to the information reading using a barcode, but preferably the RFID tag 140 has the ability to update the stored information. Thus, additional data such as the state of charge of the individual cells 118 in the cassette 34 can be stored in the RFID tag. Thus, if cassette 34 is removed and then reinserted into sterilizer 10 or even another sterilizer, control system 28 may inform the status of the individual cells 118 in cassette 34. This allows for reuse of the partially used cassette 34. In addition, since the RFID tag 140 can hold more data than the barcode 80, more data about the cassette 34 and its contents and manufacturing method can be included in the tag.

The spent collection box antenna 138 reads the spent collection box RFID tag 142 to determine whether the spent collection box 84 is present. Other data such as the unique identifier for the box 84, the capacity of the box 84, the number of cassettes 34 currently in the box 84, and the number of non-empty cells 118 therein. May be included in the RFID tag 142. The control system 28 may track how many cassettes 34 have been discharged into the box to determine whether there is space to have more of the cassettes 34 consumed. Antenna 138 may also read cassette RFID tag 140 to count the number of cassettes 34 in box 84. When the box 84 is full, the control system 28 alerts the operator by placing a message on the screen. This message may also include information about the cassettes 34 in the box 84. For example, if all cassettes 34 have not been completely ejected, this may be known to determine whether the operator will instruct carefully to dispose.

RFID technology is disclosed in the following patents which are incorporated herein by reference: US Pat. No. 6,600,420; No. 6,600,418; 5,378,880; 5,378,880; 5,565,846; 5,565,846; 5,347,280; 5,347,280; 5,541,604; 5,541,604; 4,442,507; 4,442,507; 4,796,074; 5,095,362; 5,095,362; No. 5,296,722; 5,407,851; 5,407,851; 5,528,222; 5,528,222; 5,550,547; 5,550,547; 5,521,601; 5,521,601; 5,682,143; 5,682,143; And 5,625,341.

RFID tags typically include an antenna and an integrated circuit produced in a thin film factor, and thus may be inconspicuously attached to an object such as a cassette 34. The radiofrequency energy transmitted by the antennas 136, 138 causes sufficient current in the antenna inside the RFID tags 140, 142 to power the integrated circuit therein. Some types of RFID tags have their own power source and have longer detection ranges, but at an additional cost and are not desirable for use in the present invention.

16 shows a memory map for memory in RFID tags 140 and 142. The 64-bit unique ID (UID) is set at the factory and cannot be changed. Each RFID tag has its own unique number here. 64 32-bit blocks can be programmed by the user. These blocks contain information such as date of manufacture, expiration date, product ID, serial number, lot number, place of manufacture, the state of charge of the cells, the strength and type of the disinfectant, and the time spent in the sterilizer 10.

Some fungicides are affected by heat. RFID tag 140 may optionally include a temperature collection mechanism and update its information in the tag. If the design temperature profiles are exceeded, such as maximum temperature or excessive temperature over time period, then the cassette 34 may be rejected by the control system 28. Temperature-measurement RFID tags are available from KSW-Microtec in Dresden, Germany and from Identec Solutions, Inc. in Kelowna, British Columbia, Canada. The interior of the sterilizer 10 in which the cassette 34 is placed may be higher than the ambient temperature. Therefore, it is advantageous to set the maximum residence time (storage life when mounted) on the tag 140 or to update the tag 140 at that time the cassette has already spent in the sterilization apparatus.

In order to test the sterilant measuring equipment in the sterilizer 10, it is advantageous to provide cassettes 34 with water or other fluid in one or more cells 118. Information about the particular nature of the cassette 34 and its contents can be recorded in an RFID tag.

During the cycle, the sterilizer may require only a portion of the contents of the cell 118. For example, a special cycle may request the contents of one and a half cells. Half filled properties of cell 118 may be stored and then the cell 188 may be drained for the next cycle.

Preferably, communication between tags 140 and 142 and controller 132 is encrypted. For example, the UID can be exclusive OR (XOR) by an 8-bit master key to form a diversified key that encrypts the data. Encryption algorithms such as Data Encryption Standard (DES), i.e., Triple DES, Asymmetric Encryption Standard (AES), or RSA Security, may be used for encryption. The RFID controller 132 reads the data, and the algorithm in the control system 28 decodes the data to represent the stored information.

Other methods may be used to communicate between the cassette 34 and the sterilizer 10. Information may be stored magnetically in the cassette 34, for example by a magnetically encoded strip, and read by a magnetic reader in the sterilizer. As wireless technology is declining every day, cassette 34 may include an active transmitter and power source (i.e. battery), for example an automatic RFID tag or Bluetooth, 802.11b or other communication standard.

Moreover, the sterilizer 10 may be configured to communicate with a central source, such as a manufacturer or distributor, and may provide information regarding the performance of the sterilizer and the performance of the cassettes 34. Poor performance of the cassettes 34 can be identified in the sterilizer monitors of the sterilizer, for example, as indicating any failure, such as an empty cassette or a poor sterilizer, without detecting the sterilizer during the cycle. An improperly produced batch of cassettes 34 can then be quickly identified and recalled. Such communication may be made via a telephone, pager or wireless telephone network or the Internet.

Referring now to FIGS. 17 and 18, the spent cassette collection box 84 is preferably made from a single sheet of printed circuit board or other material. FIG. 17 shows the unfolded blank 150, and FIG. 18 shows the folding of the blank 150 to form a cassette collection box 84 consumed.

The blank 150 is divided into a bottom panel 152, side panels 154, end panels 156 and top flaps 158 by a series of fold lines and cut lines. The folded tabs 160 extend laterally in the side panels 154. Additional folded tabs 162 extend laterally in the end panels 156. Barcodes 82 are printed on the side panels 154 in a position visible at the upper inner corner of the cassette collection box 84 consumed when folded in the form shown in FIG. A pair of top flap locking tabs 164 extend from the top flaps 158 to fit within the slots 166 of the opposing top flap 158 when the box 84 is closed, and the box 84 is When opened, it fits into the slots 168 at the intersection of the bottom panel 152 and the side panel 154.

When folding the box, the folding tabs 160 of the side panels 154 are folded up, and the side panels 154 are folded up, whereby the folding tabs 160 are connected to the bottom panel 152 and the end panel 156. Aligned with the intersection between them. End panels 156 are then folded up, and end panel folded tabs 162 are folded down covering the folded tabs 160. Locking tabs 170 on the end panel folding tabs 162 fit into slots 172 at the intersection between the bottom panel 152 and the end panels 156.

In order to place the box 84 in the open position shown in FIG. 18, the top flaps 158 are folded down outwards and the locking tabs 164 fit into the slots 168. Once the box 84 is filled with the spent cassette, the top flaps 158 cover the top and fold up, and the locking tabs 164 can fit into the slots 166 on the opposing top flaps 158. have. This unique folding structure allows the spent cassettes 34 to easily fall into the open box 84 without being disturbed by the top flaps 158 and also to easily close the box 84 when filled with the spent cassettes. do.

19 shows a cassette 200 similar to the cassette 34. However, the cassette 200 is installed in an outer sleeve 202 which protects the cassette 200 and the outer sleeve 202 has no droplets remaining on the cassette 200 after the sterilization cycle. Preferably, the liquid sterilant can be absorbed so as to be absorbed by. This prevents the user from contacting the disinfectant. 20 illustrates a cassette 200 in another cassette processing system 204.

In the system 204, the cassette 200 and the sleeve 202 enter through the opening 205. The rollers 207 move the cassette 200 and sleeve 202 into the system 204, where the barcode 206 on the flap 208 moves the window 211 through the sleeve 202. It is read by the barcode reader 210 that has passed and the information is passed to the control system 212. The control system 212 checks whether a suitable cassette 200 has been inserted into the system 204 and then signals the rollers 207 to extract the cassette 200 from the sleeve 202. Preferably, barcode 206 is encoded in lumen claims as described above.

When cassette 200 returns to sleeve 202, flap 208 is pushed sideways so that cassette 200 and sleeve 202 are not read when reinserted into system 204 and thereby consumed cassette Prevent 200 from being used. Of course, rather than using the flap 208, a barcode can be printed on the sleeve 202 or on the cassette 200 without the flap and visible through the window 211. In this case, the above-described method is preferably used to ensure that the cassette is not used.

Packaging for Cassettes

21 shows a packaging system 300 for a cassette 302 similar to the cassette 34. Cassette 302 is contained within a transparent liquid impermeable outer wrap 304. Label 306 and barcode 308 can be seen through wrap 304. RFID or other tags may replace or supplement the barcode 308. Wrap 304 is preferably formed of polypropylene in a transparent orientation. Absorbent web 310 attached inside of wrap 304 surrounds cassette 302 with respect to the portion containing hydrogen peroxide. The absorbent web 310 is preferably formed from a non-woven matrix of melt blown polypropylene impregnated with the superabsorbent polymer. For the purposes of the present invention, the term "superabsorbent polymer" means a material capable of absorbing and storing at least about 30 times the load of the liquid sterilant of the cassette 302 at 0.5 psig pressure. Suitable superabsorbent polymers include polyacrylamides and polyacrylates and in particular crosslinked sodium polyacrylates. One suitable superabsorbent web is Korma HY0301038, available from BPA Fiberweb, Nashville, Tennessee, USA.

The packaging system is preferably formed by attaching the absorbent web 310 to a cassette 302 disposed thereon and a sheet 312 of transparent polypropylene, for example as adhesive bonding (see FIG. 22). Sheet 312 and web 310 are wrapped around cassette 302 and edges attached to form seal 314.

Absorbent web 310 is preferably fire resistant and does not form harmful reactions with fungicides. The amount of superabsorbent polymer is preferably sufficient to absorb all fungicides in the cassette and to store without release under an externally applied pressure of 2 or 3 pounds per square inch (0.14 or 0.21 [ksc; kilogram per square centimeter]). Do. Although the sleeve in the previous embodiment can be used, it is preferably formed of a material that is also fire resistant and does not form a harmful reaction with the fungicide. A color change indicator is provided in the outer wrap 304 that indicates the presence of the fungicide and can be seen visually through it, thus warning the user not to open the wrap if the fungicide leaks from the cassette 302. When using a disinfectant that is soluble in water, the indicator may indicate the presence of water, such as ULTRA THIN WATER CONTACT INDICATOR TAPE 5559, available from 3M.

Although the present invention has been described with reference to specific embodiments, this is merely illustrative and not limiting and the appended claims should be construed as broadly as the prior art allows.

The cassette for the sterilizing device according to the present invention includes information on which the barcode on the cassette contains the model number of the sterilizing device to design the cassette and information on the cassette expiration date. By reading, it is possible to identify and to prevent the use of an out of date or broken cassette.

Claims (11)

As a cassette for a sterilizer, main body; One or more cells in the body; A barcode having information on the cassette and encoding a lumen claim therein; A cassette for a sterilizer, wherein at least one of the one or more cells contains a large amount of liquid sterilant. The method of claim 1, The bar code is a cassette for sterilizers, which encodes an identifier for the type and model of sterilizers together with lumen claims. The method of claim 1, The sterilizer cassette for sterilization apparatus containing a hydrogen peroxide solution. The method of claim 1, The lumen claim is a cassette for sterilization device that defines the length and inner diameter of the lumen. The method of claim 4, wherein And said lumen claim defines a material constituting said lumen. The method of claim 1, The bar code is a cassette for sterilizing apparatus encoding the length and the inner diameter for the lumen claim therein. The method of claim 6, Wherein the bar code is a cassette for sterilization apparatus encoded therein the material for the lumen claim. The method of claim 1, And the barcode is on a label attached to the body. The method of claim 1, The bar code is a cassette for sterilization device is printed on the main body. The method of claim 1, A sterilizer cassette comprising a plurality of cells. The method of claim 1, And a sleeve about the body, wherein the barcode is on the sleeve.

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